New FDA E-cigarette Regulations: Killing an Industry, Killing Smokers
From: The American (American Enterprise Institute)
If the FDA’s proposed regulations go into force, the likely outcome is a severe reduction in consumer choice, and thus fewer smokers quitting and more dying needlessly.
At last, after months of anticipation, the FDA finally unleashed the proposed regulatory plan — the “deeming regulations” — that the drug agency will apply to electronic cigarettes (ecigs). If these regulations go into force — and that may take years — the likely outcome is a severe reduction in consumer choice, and thus fewer smokers quitting and more dying needlessly.
The devil in the 241-page long proposed regulations is the requirement for new tobacco products to get what amounts to pre-market approval via a “new tobacco product application” (NTPA). The FDA estimates that such NTPAs will require thousands of man-hours of data collection and hundreds of thousands of dollars or more, a burden few current ecig companies will be able to survive.
The irony is that older, less reliable ecig products are grandfathered in. The Family Smoking Prevention and Tobacco Control Act (FSPTCA), the 2009 law which devolved tobacco oversight to the FDA, specifies February 15, 2007 as the cut-off date for grandfathered products: any ecigs on the market as of that date are automatically approved. Newer products can get approval by piggy-backing on those older products, if a company can show to the FDA’s satisfaction that a newer product is essentially equivalent to a grandfathered product, but perhaps only 1 percent of all ecigs and vapor products will qualify. For both the older, grandfathered products as well as new products, it’s unclear what type or level of change will trigger the NTPA requirement: it may be a modification as minor as a new flavor or an improved battery.
